MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SPINAL FIXATION SYSTEM; NKB

Model Number 15620

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible at this time.The implant has not been removed from the patient nor has the identifying lot number been provided.

Event Description

Follow up x-ray revealed the tulip of the mod screw had separated from the shank.The tulip remains attached to the rod implanted within the patient.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: NKB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604949286
• MDR Report Key: 10785649
• MDR Text Key: 216410777
• Report Number: 2027467-2020-00046
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376236124
• UDI-Public: (01)00190376236124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15620
• Device Catalogue Number: 15620
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR